Assessment of Phase 3 Randomized Clinical Trials Including Patients With Leptomeningeal Disease

Abstract

This systematic review examines the proportion of patients with leptomeningeal disease included in phase 3 randomized clinical trials for patients with metastatic breast cancer, lung cancer, and melanoma.

6th and 7th International consensus guidelines for the management of advanced breast cancer (ABC guidelines 6 and 7)

“…To date, there are a lack of high-quality clinical trial data supporting the use of specific systemic therapies in LMD despite some case series and retrospective cohort studies [ 213 ]. Patients, including those with a preserved general performance status at diagnosis of LMD, are often excluded from clinical trials in breast cancer; this is presumably due to the risk of rapidly progressing disease and short life expectancy [ 214 , 215 ]. Consequently, the results from clinical trials generally do not provide an accurate reflection of real-world clinical practice.…”